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Bethesda North Marriott Hotel and Conference Center

Oct 28, 2019 1:30 PM - Oct 28, 2019 5:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Short Course: How Much is Enough? Best Practices and Principles for the Non-Lead Constituent Part Within a Regulatory Submission for a Combination Product


Short Course* Registration: 12:30-5:00PM

This short course will provide an overview on the best practices for assembling a marketing application for a combination product. FDA’s current thinking is that a single application is generally appropriate for a combination product, the type of application depending on the primary mode of action (PMOA) of the product. In determining the information needed to demonstrate the safety and effectiveness of the product as a whole, the statutes and regulations pertaining to each constituent part must be considered.

The course will highlight two application types: a drug/device (drug-led) application, and a device/drug (device-led) application. For each type, content options to include for the non-lead constituent part will be discussed. The impact of complexity of the non-lead constituent part on the best content option will be examined. Case studies with open discussions and dialogue will be used throughout the course.

*Short Courses are not included in the meeting registration and require a separate fee.

Learning objectives

At the conclusion of this session, participants should be able to:
  • Identify the types of marketing applications for combination products
  • Outline best practices in developing a marketing application including the non-lead constituent part
  • Describe the challenges and opportunities on determining the how much non-lead constituent part data is required and where the data should be referenced within the marketing application

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